Comparison of the effect of oral captopril with sublingual captopril on blood pressure of patients referred to hospital emergency room
Design
A clinical trial with a control group with a three-way blind phase three parallel group on 138 patients, rand function of Excel software will be used for randomization.
Settings and conduct
Randomization is done through variable blocking, and for the purpose of three-way blinding and without informing the randomizer, the drug and placebo are placed in an envelope with a code, and after measuring the blood pressure of the primary subjects, the drug and placebo are prescribed to the patient. In the group prescribed oral captopril 25 mg of Elixir Pharmaceutical Company, in order to blind the patient, simultaneous sublingual placebo was prescribed, and in the group prescribed sublingual captopril 25 mg of Elixir Pharmaceutical Company and placebo were administered orally at the same time.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with systolic blood pressure above 160 or diastolic blood pressure above 100 referring to the FAST (outpatient) emergency department of Khatam al-Anbia Hospital in 1401
Exclusion criteria: 1) Patients who need blood pressure injection treatment and hospitalization. 2) Patients who have used blood pressure pills an hour before the visit. 3) Patients who have a history of kidney problems. 4) Patients who are over 65 years old. 5 ) Patients who are younger than 18 years old 6) Patients with end organ damage
7) Pregnancy 8) Decreased level of consciousness
Intervention groups
After randomization, patients are divided into two groups and receive either oral captopril or sublingual captopril.
Main outcome variables
Blood pressure ؛ blood pressure assessment time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054869N2
Registration date:2022-08-08, 1401/05/17
Registration timing:prospective
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
ali abdolrazaghnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3323 2890
Email address
ali.abdolrazaghnejad@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral captopril with sublingual captopril in lowering blood pressure in patients with acute high blood pressure
Public title
Comparison of the effect of oral captopril with sublingual captopril in lowering blood pressure in patients with acute high blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with systolic blood pressure above 160 or diastolic blood pressure above 100 referred to the FAST (outpatient) emergency department of Khatam Al-Anbia Hospital in 1401
Exclusion criteria:
Patients who need blood pressure injection treatment and hospitalization
Patients who have used blood pressure pills an hour before the visit
Patients who have a history of kidney problems
Patients with end organ damage
Pregnancy
Decreased level of consciousness
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to two groups is done by permuted block stratified randomization method designed with Random allocation software. In this way, first, eligible referring patients are classified according to age and gender in the order of entry. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. In order to hide the random allocation, envelopes will be used in the package.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research, the triple-blind method is used. The patients will receive both forms of administration (sublingual and oral) with drugs and placebo and will be blinded to being in the intervention or control group. The data collector measures the desired outcomes and does not know which group the patient is in. The data analyst compares two groups coded A and B and is blinded to the control and intervention groups. .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square - Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
43463 - 98167
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.ZAUMS.REC.1401.151
Health conditions studied
1
Description of health condition studied
Acute hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Decreased blood pressure by more than 10 mm Hg
Timepoint
30, 10 and 60 minutes
Method of measurement
alpk2 300v mercury pressure gauge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Sublingual captopril of Exir pharmaceutical company 25 mg once after entering the study
Category
Treatment - Drugs
2
Description
Control group: Oral captopril 25 mg of Exir pharmaceutical company is prescribed to the patient after entering the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Khatam al-Anbia Hospital, Zahedan
Full name of responsible person
Ali Abdolrazaghnejad
Street address
Khatam Square - Khatam Al Anbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 3003
Email
ali.abdorazzagh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Normohammad Bakhshani
Street address
Pardis square - University of Medical Sciences - Research Vice-Chancellor
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3337 2117
Email
dr.bakhshani35@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abdolrazaghnejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khatam Square - Khatam Al Anbia Hospital - Department of Emergency Medicine
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 3003
Email
ali.abdorazzagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abdolrazaghnejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khatam Square - Khatam Al Anbia Hospital - Department of Emergency Medicine
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 3003
Email
ali.abdorazzagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abdolrazaghnejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khatam Square - Khatam Al Anbia Hospital - Department of Emergency Medicine
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 3003
Email
ali.abdorazzagh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 12 months after the results are published
To whom data/document is available
Seas of documents will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For medical purposes, pharmaceutical companies can receive data analysis after sending a request.
From where data/document is obtainable
Applicants should write to the following postal address.
ali.abdorazzagh@gamil.com
What processes are involved for a request to access data/document
After sending the request to the said postal address, as well as stating the purpose of accessing the data and documents, the applicant will receive the documents within a period of 12 weeks, if there is no conflict with the codes of medical ethics.